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Speaking Of Medtech, Ep. 9: The Case For Compliance
In this episode of Speaking Of Medtech: Over the past decade or so the US FDA and many device makers have been advocating for quality over compliance, but what if promoting compliance was seen as a good goal for the medtech industry?
More from Compliance
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
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A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.
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The New Civil Liberties Alliance, which represented a plaintiff in the lawsuit last summer that ended court deference to federal agencies, is asking for a stay on the consumer protection agency’s rule on infant support cushions. The law firm argues that CPSC wrongly used an expedited process to issue the rule.
More from Policy & Regulation
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.